Verve Therapeutics Inc. surged in premarket trading after US drug regulators lifted their hold on the company’s application to start human testing of a gene-editing treatment for people with high cholesterol.
Last year, the Food and Drug Administration paused the company’s plan for US testing of a therapy aimed at altering a cholesterol-raising gene in order to prevent heart attacks. Verve has addressed the FDA’s questions and shared interim clinical data with the agency, according to a company statement on Monday.
Verve rose as much as 13% as of 7:26 a.m. in New York. If the gain holds into regular trading, the stock will be set for its biggest rise since Sept. 26.
The news is a positive sign for the burgeoning field of gene editing, which aims to make permanent changes in human DNA in order to treat — and potentially cure — diseases. Drug developers and patients are looking to the technology to address some of the most intractable disorders, such as sickle cell disease. Yet concerns about the safety of altering human DNA has raised concerns about the safety of patients themselves, as well as their potential offspring.
The FDA’s decision is “a significant milestone,” Verve Chief Scientific Officer Andrew Bellinger said in the statement. Verve has already started testing the treatment in New Zealand and the UK.
Read More: Crispr, the Tool Giving DNA Editing Promise and Peril: QuickTake
Regulators asked for more information around potency, unintended changes in patients’ DNA and the risks that gene alterations pose to potential offspring, Boston, Massachusetts-based Verve said in December. The FDA suggested Verve add tighter contraceptive requirements and lengthen the time between treatment doses, while requesting data from trials taking place outside the US.
Verve is scheduled to report interim clinical data from its trial on Nov. 12 at a meeting of the American Heart Association.
This story was produced with the assistance of Bloomberg Automation.
(Updates with shares in first and third paragraphs.)
